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Pandemic Flu Monitor: FDA OKs Experimental Emergency IV Drug for Adults When It Is Only Choice Doctors Have

Cheree Cleghorn | October 25, 2009

Medpage Today

The investigational antiviral peramivir can be used against the H1N1 pandemic flu in certain critically ill patients, the FDA has announced.

Acting on a request from the CDC, the agency issued an emergency use authorization for the drug, which is the only antiviral designed to be administered intravenously. (Emphasis added)

The FDA said the drug – a neuraminidase inhibitor — can be used for adult or pediatric inpatients when:

  • “The patient is not responding to either oral or inhaled antiviral therapy.
  • “When drug delivery by a route other than intravenous — enteral or inhaled — is not expected to be dependable or feasible. (Emphasis added)

“The agency also said the drug can be used for adults only, when the clinician judges intravenous treatment is appropriate for other reasons. (Emphasis added)

There are no FDA-approved intravenous antivirals for influenza. Peramivir is the only such therapy authorized for use under an emergency use authorization for pandemic flu infections. (Emphasis added)

“Last spring, however, clinicians in the United Kingdom used an intravenous formulation of zanamivir (Relenza) to treat an H1N1 patient who had not responded to oral oseltamivir (Tamiflu) or inhaled zanamivir. (See Swine Flu Patient Recovers After Last-Ditch Zanamivir Shots)”

Source: Medpage Today, October 24, 2009



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